2022-10-24T14:05:38-05:00 2021-12-31 440160260 FORVIS LLP 901 EAST CARY STREET SUITE 1000 RICHMOND VA 23219 990 2021-01-01 521986675 FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH INC FOUN 3014025311 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 DONALD M HILL CHIEF FINANCIAL OFFICER 3014025311 2022-10-21 1 DONALD HILL 999009999 LAKRISHA J WATSON P01677333 8042827636 2022-10-21 3 AAL1 IAL1 2021 2022-09-23 18:48:47Z DONALD M HILL 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 119637840 0 X HTTP://WWW.FNIH.ORG X 1996 MD THE FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH CREATES AND MANAGES ALLIANCES WITH PUBLIC ANDPRIVATE INSTITUTIONS IN SUPPORT OF THE MISSION OF THE NIH, THE WORLD'S PREMIER MEDICAL RESEARCH AGENCY. THE FOUNDATION, ALSO KNOWN AS THE FNIH, WORKS WITH ITS PARTNERS TO ACCELERATE BIOMEDICAL RESEARCH AND STRATEGIES AGAINST DISEASES AND HEALTH CONCERNS IN THE UNITED STATES AND ACROSS THE GLOBE. THE FNIH ORGANIZES AND ADMINISTERS RESEARCH PROJECTS; SUPPORTS EDUCATION AND TRAINING OF NEW RESEARCHERS; ORGANIZES EDUCATIONAL EVENTS AND SYMPOSIA; AND ADMINISTERS A SERIES OF FUNDS SUPPORTING A WIDE RANGE OF HEALTH ISSUES. ESTABLISHED BY CONGRESS IN 1990, THE FNIH IS A NOT-FOR-PROFIT 501(C)(3) CHARITABLE ORGANIZATION. 24 24 86 24 0 0 98343956 105993785 0 50000 1793315 1523894 42551 38012 100179822 107605691 23094805 20925571 0 0 11036676 11200771 0 0 112270 24522875 26276294 58654356 58402636 41525466 49203055 171939741 221939759 10735525 10990437 161204216 210949322 X SEE SCHEDULE O, STATEMENT OF ORGANIZATION'S PRIMARY EXEMPT PURPOSE STATEMENTTHE FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH CREATES AND LEADS ALLIANCES AND PUBLIC-PRIVATE PARTNERSHIPS THAT ADVANCE BREAKTHROUGH BIOMEDICAL DISCOVERIES AND IMPROVE THE QUALITY OF PEOPLE'S LIVES. 0 0 50592188 19914025 50000 SEE SCHEDULE O, PROGRAM ONE, RESEARCH PROGRAMSPROGRAM ONE - RESEARCH PROGRAMS -ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV)COMBATING THE PANDEMIC WHEN DESPERATELY ILL COVID-19 PATIENTS FIRST BEGAN KNOCKING AT THE DOORS OF U.S. HOSPITALS, HEALTHCARE WORKERS FRANTICALLY SOUGHT TO DEVELOP EFFECTIVE TREATMENTS FOR THE DISEASE. ACROSS THE WORLD, INDIVIDUAL SCIENTISTS AS WELL AS RESEARCH INSTITUTIONS LAUNCHED HUNDREDS OF STUDIES TO TEST VARIOUS POTENTIAL REMEDIES. UNFORTUNATELY, MANY OF THESE STUDIES WERE TOO SMALL OR INADEQUATELY DESIGNED TO YIELD CONCLUSIVE RESULTS. MEANWHILE, A NUMBER OF UNSUBSTANTIATED REPORTS OF "EFFECTIVE" TREATMENTS FLOODED THE MEDIA, WHICH DID LITTLE TO RELIEVE THE "INFODEMIC" OVERWHELMING THE HEALTHCARE WORKERS TRYING TO HELP THESE PATIENTS.A NATIONALLY COORDINATED, FOCUSED PLAN FOR ADDRESSING THE PANDEMIC WAS CLEARLY NEEDED AND DR. FRANCIS COLLINS CALLED ON THE FNIH TO CREATE A SOLUTION. THE RESULTING ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV) PARTNERSHIP WAS FORMED IN RECORD TIME IN APRIL 2020. OVER THE FOLLOWING 10 MONTHS, ACTIV REVIEWED MORE THAN 800 POTENTIAL COVID-19 TREATMENTS AND LAUNCHED 11 ROBUSTLY DESIGNED "MASTER PROTOCOL" CLINICAL TRIALS, EACH CAPABLE OF TESTING MULTIPLE DRUGS IN A RELEVANT PATIENT POPULATION AND FUNDED THROUGH NIH BY THE U.S. GOVERNMENT'S OPERATION WARP SPEED INITIATIVE. SINCE ITS INCEPTION IN APRIL 2020, THE ACTIV TRIAL NETWORKS HAVE TESTED OVER 30 THERAPIES FOR EFFECTIVENESS AGAINST COVID-19.OF THESE PROMISING LEADS, SEVERAL HAVE ALREADY REPORTED RESULTS, WITH A MAJORITY OF THE TRIALS DUE TO READ OUT BY THE FALL OF 2022. DURING 2021, DATA FROM THE ACTIV TRIALS CONTRIBUTED TO EMERGENCY USE AUTHORIZATIONS FOR THREE TREATMENTS, INCLUDING THE MONOCLONAL ANTIBODY THERAPIES FROM BRII BIOSCIENCES, ELI LILLY, AND ASTRAZENECA, AND LED TO AN IMPORTANT CHANGE IN CLINICAL PRACTICE FOR THE USE OF ANTICOAGULATION THERAPIES IN HOSPITALIZED COVID-19 PATIENTS. IMPORTANTLY, ACTIV'S PRIORITIZATION EFFORTS MEANT THAT VALUABLE RESOURCES MONEY, LABORATORY SPACE, HEALTHCARE WORKERS' TIME, AND PATIENTS' HOPES WERE FOCUSED ON THERAPIES LIKELY TO SUCCEED AS COVID-19 TREATMENTS.ACTIV, WHICH INCLUDES EIGHT U.S. GOVERNMENT AGENCIES, FOUR NONPROFIT ORGANIZATIONS, AND 20 INDUSTRY PARTNERS, STANDS OUT AS PERHAPS THE MOST REMARKABLE COLLABORATION TO ARISE FROM THE COVID-19 RESPONSE. ITS FORMATION RELIED ON THE FNIH'S PROVEN PARTNERSHIP MODEL ENGAGE PEOPLE AND ORGANIZATIONS WITH DIVERSE KNOWLEDGE, UNIQUE CAPABILITIES, AND DISTINCT VIEWPOINTS AND CREATE AN ENVIRONMENT BASED ON OBJECTIVE SCIENCE WHERE TRUST AND THE EXCHANGE OF NEW IDEAS CAN THRIVE WHILE ACHIEVING ITS GOALS WITH UNPRECEDENTED SCALE AND SPEED. IT'S A BLUEPRINT THAT THE FNIH WILL CONTINUE TO FOLLOW TO TACKLE A HOST OF DIFFICULT BIOMEDICAL CHALLENGES STEMMING FROM THE CURRENT PANDEMIC AND MANY FUTURE CHALLENGES TO HUMAN HEALTH. TRACEIN EARLY 2020, SCIENTISTS AT THE NIH AND AROUND THE WORLD QUICKLY HAD SEQUENCED THE NEW SARS-COV-2 VIRUS AND HAD BEGUN TO CREATE EFFECTIVE TOOLS FOR STOPPING IT. BUT THEN CAME THE BETA VARIANT. GAMMA, DELTA, AND, MOST RECENTLY, OMICRON VARIANTS FOLLOWED. EACH SUCCESSIVE WAVE OF THE CORONAVIRUS CAUSED DEATH AND DISRUPTION ACROSS THE GLOBE AND THREATENED TO DIMINISH THE EFFECTIVENESS OF NEWLY AVAILABLE COVID-19 VACCINES AND THERAPIES.THE URGENCY OF TRACKING AND STUDYING THESE VARIANTS BECAME PAINFULLY CLEAR. WHILE A VARIETY OF PLATFORMS WERE AND CONTINUE TO BE USED BY DIFFERENT COUNTRIES TO SEQUENCE AND SHARE VIRUS DATA, THE FNIH AND NIH RECOGNIZED EARLY ON THAT A COORDINATED, GLOBAL PERSPECTIVE IS ESSENTIAL TO UNDERSTAND THE EVOLUTION OF THE VIRUS AND THE IMPACT OF VARIANTS ON THERAPEUTICS AND VACCINES. IN JANUARY 2021, THE FNIH CONVENED GOVERNMENT AGENCIES, ACADEMICS, AND PRIVATE PARTNERS TO ESTABLISH THE ACTIV TRACKING RESISTANCE AND CORONAVIRUS EVOLUTION (TRACE) INITIATIVE. THROUGH GENOMIC SURVEILLANCE, DATA SHARING, AND ASSESSMENTS OF TREATMENT RESPONSES TO NEW VIRUS STRAINS, TRACE STANDARDIZES AND CONSOLIDATES DATA FROM GENETIC DATABASES WORLDWIDE TO MONITOR AND TEST COVID-19 VARIANTS. TRACE ALSO ASSESSES VACCINE AND THERAPEUTIC RESISTANCE AND EVALUATES THE IMPACT OF GENETIC VARIATION ON VIRAL BIOLOGY AND ON THE CLINICAL APPROACHES FOR PREVENTING AND TREATING ILLNESS. TRACE HAS SUCCESSFULLY COMPILED ALL OF THIS CRITICAL INFORMATION INTO ONE CLEAR, PUBLICLY ACCESSIBLE PLATFORM AT THE NIH'S NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES AND IS RAPIDLY SHARING DATA ON COVID-19 VARIANTS WITH THE ENTIRE GLOBAL SCIENTIFIC COMMUNITY. THE BESPOKE GENE THERAPY CONSORTIUMRARE DISEASES ARE DEFINED IN THE U.S. AS THOSE THAT AFFECT FEWER THAN 200,000 PEOPLE WITH SOME AFFLICTING AS FEW AS 10 INDIVIDUALS IN THE WORLD. BUT COLLECTIVELY THESE DISEASES ARE RESPONSIBLE FOR WIDESPREAD HARM. SOME 25 TO 30 MILLION AMERICANS, AS WELL AS THEIR FAMILIES AND COMMUNITIES, SUFFER FROM THE APPROXIMATELY 7,000 RARE DISEASES KNOWN TODAY, WITH FEW EFFECTIVE TREATMENTS. ONE TYPE OF TREATMENT HAS EMERGED THAT OFFERS HOPE: GENE THERAPY, A PROCESS THAT REPLACES DEFECTIVE GENES THAT CAUSE DISEASE WITH FUNCTIONAL ONES. WHILE GENE THERAPIES HAVE BEEN SUCCESSFULLY USED TO TREAT COMMON GENETIC DISEASES, THEY CAN ALSO BE TAILORED (OR "BESPOKE") FOR MUCH SMALLER POPULATIONS. DEVELOPING THESE THERAPIES, HOWEVER, IS COMPLEX AND OFTEN EXPENSIVE, AND SMALL PATIENT POPULATIONS MAKE IT CHALLENGING TO GET AN ADEQUATE RETURN ON INVESTMENT IN THE DEVELOPMENT PROCESS. THE BESPOKE GENE THERAPY CONSORTIUM (BGTC) PROMISES TO CHANGE THE PLAYING FIELD FOR GENE THERAPY DEVELOPMENT. LAUNCHED IN LATE 2021 BY THE FNIH, NIH, AND FDA, THE BGTC AIMS TO GENERATE A STANDARDIZED "PLUG-AND-PLAY" TEMPLATE THAT MAKES IT EASIER TO DEVELOP NEW GENE THERAPIES. RATHER THAN CREATING A CUSTOM THERAPY FOR EACH DISEASE FROM SCRATCH, DEVELOPERS COULD SOON BE ABLE TO USE AND REUSE THIS COMMON TEMPLATE TO PRODUCE THERAPIES MORE QUICKLY AND AT LOWER COST. THE BGTC IS THE LATEST INITIATIVE TO EMERGE FROM THE FNIH'S HIGHLY SUCCESSFUL ACCELERATING MEDICINES PARTNERSHIP (AMP) PROGRAM. BUILDING ON THE AMP COLLABORATION MODEL, THE BGTC PROGRAM BRINGS TOGETHER 30 PUBLIC AND PRIVATE SECTOR ORGANIZATIONS, INCLUDING MANY RARE DISEASE PATIENT GROUPS, TO SUPPORT A SERIES OF RESEARCH PROJECTS AND CLINICAL TRIALS INTENDED TO REFINE AND STANDARDIZE TRIAL DESIGN, REGULATORY EVALUATION, AND MANUFACTURING PROCESSES, ENABLING THE FIELD TO DELIVER MORE VIABLE TREATMENTS FOR RARE DISEASES TO MORE PATIENTS.ACCELERATING MEDICINES PARTNERSHIP (AMP) PROGRAMSTHE FNIH LAUNCHED THE FIRST THREE ACCELERATING MEDICINES PARTNERSHIP PROGRAMS TOGETHER WITH THE NIH IN 2014. FOCUSED ON ALZHEIMER'S DISEASE, TYPE 2 DIABETES, AND RHEUMATOID ARTHRITIS AND LUPUS, THE FIRST AMP PROGRAMS GENERATED GENOMIC AND MOLECULAR DATA AND ANALYTICAL APPROACHES THAT HAVE SUBSTANTIALLY ADVANCED OUR UNDERSTANDING OF DRUG TARGETS IN THESE DISEASES. THESE THREE PARTNERSHIPS HAVE PROVED SO SUCCESSFUL THAT EACH HAS NOT ONLY PRODUCED FOLLOW-ON EFFORTS THAT CONSIDERABLY EXPAND THEIR ORIGINAL RESEARCH AGENDAS, BUT THEY HAVE ALSO INSPIRED COMPLETELY NEW AMP PROGRAMS IN PARKINSON'S DISEASE, SCHIZOPHRENIA, AND GENE THERAPIES.ACCELERATING MEDICINES PARTNERSHIP AND AMP ARE REGISTERED SERVICE MARKS OF THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES.NON-INVASIVE BIOMARKERS OF METABOLIC LIVER DISEASE (NIMBLE)NON-ALCOHOLIC STEATOHEPATITIS (NASH) IS A SERIOUS LIVER DISEASE ESTIMATED TO AFFECT BETWEEN 9 AND 15 MILLION PEOPLE IN THE U.S. THE DISEASE OFTEN REMAINS UNDIAGNOSED IN ITS EARLY STAGES AND CAN REQUIRE A LIVER TRANSPLANT OR CAUSE LIVER CANCER AND ULTIMATELY DEATH. CURRENTLY, DIAGNOSING EARLY-STAGE NASH REQUIRES A LIVER BIOPSY, A PAINFUL, INVASIVE, AND EXPENSIVE PROCESS.IN NOVEMBER 2021, THE FNIH BIOMARKERS CONSORTIUM RELEASED THE INITIAL RESULTS FROM ITS NIMBLE PROJECT, WHICH SEEKS TO ASSESS THE SUITABILITY OF SEVERAL NON-INVASIVE, BLOOD-BASED BIOMARKERS FOR USE IN CLINICAL TRIALS OF TREATMENTS FOR NASH. SEVERAL OF THESE BIOMARKERS DID A BETTER JOB OF IDENTIFYING PATIENTS AT RISK OF DEVELOPING NASH OR PROGRESSING TO CIRRHOSIS THAN CURRENT STANDARD TESTS AND COMPARED FAVORABLY WITH THE DIAGNOSTIC PERFORMANCE OF LIVER BIOPSY, THE CURRENT REFERENCE STANDARD. ALTHOUGH FURTHER CONFIRMATORY STUDY MAY BE REQUIRED, THE NEW BIOMARKERS EXAMINED BY NIMBLE COULD POTENTIALLY REPLACE THE NEED FOR PATIENTS WHO HAVE OR WHO MAY BE AT RISK FOR NASH TO UNDERGO BIOPSIES. IF APPROVED BY THE FDA, TESTS USING THESE NEW MARKERS COULD ENABLE EARLY AND ACCURATE DIAGNOSIS OF AT-RISK PATIENTS, IMPROVING THE QUALITY OF CARE, ACCELERATING DRUG DEVELOPMENT, AND REDUCING THE BURDEN IMPOSED BY CURRENT CLINICAL CARE PRACTICES. 1310343 1011545 SEE SCHEDULE O, PROGRAM TWO, AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMSPROGRAM TWO - AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMS - ONE OF THE MANY WAYS THE FNIH ACCELERATES PROGRESS IS THROUGH INVESTMENT IN THE CREATIVITY OF EXCEPTIONAL SCIENTISTS. THE ORGANIZATION BESTOWS THREE PRIZES EACH YEAR TO RECOGNIZE OUTSTANDING PARTNERS AND CONTRIBUTORS TO ADVANCING BIOMEDICAL RESEARCH. 2021 FNIH AWARDS THE LURIE PRIZE IN BIOMEDICAL SCIENCESTHE LURIE PRIZE IN BIOMEDICAL SCIENCES IS AN ANNUAL AWARD GIVEN TO PROMISING YOUNGER INVESTIGATORS WHO HAVE ACHIEVED GROUNDBREAKING ADVANCES IN BIOMEDICAL SCIENCE. THE PRIZE IS MADE POSSIBLE BY A GENEROUS GIFT FROM NOTED PHILANTHROPIST AND FNIH HONORARY BOARD MEMBER ANN LURIE. IN 2021, THE FNIH HONORED XIAOWEI ZHUANG, PH.D., FOR HER REVOLUTIONARY WORK DEVELOPING SUPER-RESOLUTION MICROSCOPY AND GENOME-SCALE IMAGING THAT REVEALED NEW SPATIAL AND FUNCTIONAL ORGANIZATIONS OF MOLECULES AND CELLS. DR. ZHUANG'S INNOVATIVE WORK WITH MICROSCOPY HAS ENABLED RESEARCHERS TO VISUALIZE WITH HIGH RESOLUTION THE POSITIONING OF AND INTERACTIONS BETWEEN MOLECULES IN A CELL, AS WELL AS THE SPATIAL ORGANIZATION OF DISTINCT TYPES OF CELLS IN TISSUES. HER DISCOVERIES HAVE MADE A SIGNIFICANT IMPACT ACROSS THE FIELD OF BIOLOGY, WITH SEMINAL APPLICATIONS TO CELL BIOLOGY.DR. ZHUANG IS A PROFESSOR AT HARVARD UNIVERSITY, A HOWARD HUGHES MEDICAL INSTITUTE INVESTIGATOR, AND CO-FOUNDER OF THE LIFE SCIENCES COMPANY VIZGEN.TRAILBLAZER PRIZE FOR CLINICIAN-SCIENTISTSTHE TRAILBLAZER PRIZE FOR CLINICIAN-SCIENTISTS WAS ESTABLISHED IN 2018 TO HIGHLIGHT THE ESSENTIAL ROLE OF EARLY CAREER CLINICIAN-SCIENTISTS WHOSE RESEARCH HAS LED OR HAS THE POTENTIAL TO LEAD TO INNOVATIONS IN PATIENT CARE.IN 2021, PIRO LITO, M.D., PH.D., ASSOCIATE MEMBER AND ATTENDING PHYSICIAN AT MEMORIAL SLOAN KETTERING CANCER CENTER, WAS AWARDED THE PRIZE FOR CATALYZING BREAKTHROUGHS IN THE UNDERSTANDING OF ONCOPROTEIN SIGNALING AND THE DEVELOPMENT OF NOVEL THERAPEUTIC APPROACHES FOR CANCERS DRIVEN BY THE MUTANT KRAS PROTEIN.WORKING AT THE INTERFACE OF BASIC RESEARCH AND CLINICAL PRACTICE, DR. LITO STUDIES HOW MUTATED PROTEINS DRIVE TUMOR GROWTH. HE IS PARTICULARLY INTERESTED IN A PROTEIN CALLED KRAS, WHICH IS COMMONLY MUTATED IN LUNG, COLORECTAL, AND PANCREATIC CANCERS. DR. LITO HAS UNCOVERED HOW MUTANT KRAS TRANSITIONS BETWEEN ITS ACTIVE AND INACTIVE STATES IN CANCER CELLS AND, BY EXPOSING VULNERABLE EVENTS DURING THIS TRANSITION, HE HAS MADE KEY CONTRIBUTIONS TO THE DEVELOPMENT OF NOVEL CANCER THERAPIES THAT ARE CURRENTLY IN CLINICAL TRIALS.FUNDING FOR THE TRAILBLAZER PRIZE IS PROVIDED BY THE GALLIN FUND AT THE FNIH.CHARLES A. SANDERS, M.D., PARTNERSHIP AWARDEACH YEAR, THE FNIH BESTOWS THE CHARLES A. SANDERS, M.D., PARTNERSHIP AWARD TO RECOGNIZE PEOPLE OR ORGANIZATIONS THAT HAVE MADE PARTICULARLY SIGNIFICANT CONTRIBUTIONS TO THE FOUNDATION'S EFFORTS TO BUILD, IMPLEMENT, AND NURTURE PUBLIC-PRIVATE PARTNERSHIPS IN SUPPORT OF THE MISSION OF THE NIH.IN 2021, THE FNIH PRESENTED THE PARTNERSHIP AWARD TO JANSSEN RESEARCH & DEVELOPMENT, LLC, AND TO THE EIGHT CO-CHAIRS OF THE ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV) WORKING GROUPS.JANSSEN RESEARCH & DEVELOPMENT, LLC, HAS BEEN AN EXEMPLARY PARTNER AND LEADER ACROSS MANY FNIH PROGRAMS, INCLUDING ACTIV, SEVERAL ACCELERATING MEDICINES PARTNERSHIPS, THE BIOMARKERS CONSORTIUM, THE PARTNERSHIP FOR ACCELERATING CANCER THERAPIES (PACT), AND THE ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE (ADNI). THE MANY JANSSEN SCIENTISTS WHO HAVE PARTICIPATED IN THESE PARTNERSHIPS HAVE CONSISTENTLY PROMOTED A HIGHLY COLLEGIAL, COLLABORATIVE APPROACH TO PROBLEM-SOLVING WITH AN EMPHASIS ON TEAMWORK AND TRANSPARENT COMMUNICATION THAT ENABLES OPEN, PRECOMPETITIVE SCIENCE.IN SUPPORT OF FINDING THERAPEUTICS AND VACCINES TO COMBAT COVID-19, THE ACTIV WORKING GROUP CO-CHAIRS SPENT COUNTLESS HOURS COLLABORATING WITH THE FNIH AND NIH TO DESIGN STRATEGIES FOR COMBATING THE COVID-19 PANDEMIC AND EXECUTE THEM WITH UNPRECEDENTED SPEED. THEY PARTICIPATED IN HUNDREDS OF MEETINGS, REPORTING REGULARLY TO THE ACTIV LEADERSHIP TEAM, AND DEVOTED VALUABLE TIME AND EFFORT TO IDENTIFY OPPORTUNITIES FOR AND HELP RESOLVE CHALLENGES TO THE PARTNERSHIP. THEIR ALL-OUT EFFORTS WERE ESSENTIAL TO ENABLING ACTIV TO NAVIGATE THE RAPIDLY CHANGING NATURE OF THE THREATS TO GLOBAL HUMAN HEALTH POSED BY SARS-COV-2.THE CO-CHAIRS OF THE ACTIV WORKING GROUPS:CHRISTINE M. COLVIS, PH.D., DIRECTOR OF DRUG DEVELOPMENT PARTNERSHIP PROGRAMS, NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS) AT NIHELIZABETH DESROSIERS, M.S., P.M.P., EXECUTIVE DIRECTOR OF CLINICAL SCIENCES AND STUDY MANAGEMENT AT MERCK & CO., INC.ERIC HUGHES, M.D., PH.D., GLOBAL DEVELOPMENT UNIT HEAD OF IMMUNOLOGY, HEPATOLOGY AND DERMATOLOGY, AND CHI-NOVARTISKATHRIN JANSEN, PH.D., SENIOR VICE PRESIDENT AND HEAD OF VACCINE RESEARCH AND DEVELOPMENT AT PFIZERMICHAEL KURILLA, M.D., PH.D., DIRECTOR, DIVISION OF CLINICAL INNOVATION, NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS) AT NIHDOUGLAS LOWY, M.D., PRINCIPAL DEPUTY DIRECTOR, NATIONAL CANCER INSTITUTE (NCI) AT NIHSARAH READ, M.D., DEPUTY DIRECTOR, DIVISION OF AIDS, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) AT NIH JOHN YOUNG, PH.D., GLOBAL HEAD OF INFECTIOUS DISEASES AND VICE PRESIDENT AT ROCHEFUNDING FOR THE CHARLES A. SANDERS, M.D., PARTNERSHIP AWARD IS PROVIDED BY THE CHARLES A. SANDERS LEGACY FUND AT THE FNIH.EVENTS AND EDUCATIONTHE MEETINGS AND EVENTS DEPARTMENT CONCEPTUALIZES, PLANS, EXECUTES AND EVALUATES HIGH-QUALITY, PRODUCTIVE, INNOVATIVE AND ECONOMICAL CONVENINGS THAT ADVANCE THE ORGANIZATION'S MISSION. THESE CONVENINGS INCLUDE, BUT ARE NOT LIMITED TO, RESEARCH PROJECT TEAM MEETINGS AND CONFERENCES, DONOR STEWARDSHIP LECTURES AND SYMPOSIA AND SPECIAL EVENTS. THE DEPARTMENT OVERSEES THE MANAGEMENT OF FNIH HIGHLY RESPECTED AWARDS AND PRIZES. SOME OF THE FNIH'S MARQUEE EVENTS IN 2021 INCLUDED: THE FNIH AWARDS CEREMONY, THE CANCER STEERING COMMITTEE'S ANNUAL SYMPOSIUM, AND THE GENECONVENE GLOBAL COLLABORATIVE WEBINARS SERIES.THE FNIH SUPPORTS A NUMBER OF EDUCATIONAL AND TRAINING OPPORTUNITIES AT NIH, RANGING FROM HIGH SCHOOL TO POSTGRADUATE FELLOWSHIPS AND TRAINING. MANY OF THESE FELLOWSHIPS AND TRAININGS ARE ESTABLISHED BY INDIVIDUALS WHO SEEK TO SUPPORT THE NEXT GENERATION OF SCIENTISTS. EXAMPLES INCLUDE:- THE JAYNE KOSKINAS TED GIOVANIS FOUNDATION FOR HEALTH AND POLICY SUPPORTS INTRAMURAL RESEARCH TRAINING AWARDS FOR DESERVING YOUNG SCHOLARS IN THE NIH INTRAMURAL TRAINING PROGRAM.- THE DEAN R. O'NEILL RENAL CELL CANCER RESEARCH FUND AND THE DR. EDWARD T. RANCIC MEMORIAL FUND FOR CANCER RESEARCH JOINTLY SUPPORT A FELLOW IN THE LABORATORY OF DR. RICHARD CHILDS AT THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE TO EXPLORE TREATMENTS FOR RENAL CELL CARCINOMA.- THE ESTATE OF SALLIE ROSEN KAPLAN ESTABLISHED THE SALLIE ROSEN KAPLAN POSTDOCTORAL FELLOWSHIP FOR WOMEN SCIENTISTS IN CANCER RESEARCH (SRK FELLOWSHIP). THE SRK FELLOWSHIP IS A HIGHLY COMPETITIVE, UNPAID, ANNUAL, ONE-YEAR PROGRAM THAT PROVIDES ADDITIONAL MENTORING OPPORTUNITIES, NETWORKING, SEMINARS AND WORKSHOPS TO FEMALE NATIONAL CANCER INSTITUTE POSTDOCTORAL FELLOWS TO HELP THEM PREPARE FOR THE COMPETITIVE JOB MARKET AND HELP THEM TO TRANSITION TO INDEPENDENT RESEARCH CAREERS. 53512 0 0 SEE SCHEDULE O, PROGRAM THREE, PATIENT SUPPORT PROGRAM/CAPITAL PROJECTPROGRAM THREE - PATIENT SUPPORT PROGRAM/CAPITAL PROJECT -FILLING A NEED OF THE NATION'S LEADING RESEARCH CENTERAT THE NIH CLINICAL CENTER THE NATION'S PREMIER HOSPITAL SOLELY DEVOTED TO CLINICAL INVESTIGATION PATIENTS ARE CONSIDERED "ACTIVE PARTNERS IN MEDICAL DISCOVERY," PARTICIPATING IN EXPERIMENTAL TRIALS CARRIED OUT BY NIH INSTITUTES TO RECEIVE TREATMENT FOR THEIR CONDITIONS AND ULTIMATELY BENEFIT SCIENTIFIC PROGRESS. THE EXTENSIVE LIST OF RESEARCH BREAKTHROUGHS COMING OUT OF THE NIH CLINICAL CENTER INCLUDES THE FIRST CURES FOR CHILDHOOD LEUKEMIA AND HODGKIN'S DISEASE USING CHEMOTHERAPY, THE FIRST BLOOD TESTS FOR AIDS AND HEPATITIS, AND THE FIRST GENE THERAPY, TO NAME JUST A FEW. TO SUPPORT SUCH RESOURCE-INTENSIVE ENDEAVORS, THE FNIH ESTABLISHED THE CLINICAL CENTER IN-KIND DRUG DONATION PROGRAM TO DONATE PHARMACEUTICALS TO THE NIH CLINICAL CENTER. THE PROGRAM, WHICH HAS PROVIDED NEARLY $16 MILLION IN DRUGS AND THERAPEUTICS TO THE NIH SINCE 2008, WAS SUPPORTED IN 2019 BY A MAJOR GIFT FROM HORIZON THERAPEUTICS PLC. "THE GENEROSITY OF THE PROGRAM HAS BEEN A MAJOR BOON TO OUR PATIENTS AND OUR PROGRAM," SAYS DR. STEVEN HOLLAND, DIRECTOR, DIVISION OF INTRAMURAL RESEARCH AT NIAID. 51956043 1 1 0 1 0 1 0 0 0 1 1 0 0 0 1 1 1 0 0 0 1 1 0 0 1 0 0 1 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 35 0 1 86 1 0 0 0 0 0 1 1 0 0 0 0 0 0 X 24 24 1 0 1 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MD VA NY AL AR CA FL GA HI IL KS KY MA MI MS MN NH NJ NM OR PA RI SC TN UT WV WI X X DONALD M HILL 3014356246 11400 ROCKVILLE PIKE SUITE 600 NORTH BETHESDA MD 20852 DR STEVEN M PAUL CHAIRMAN 1.50 X X 0 0 0 DR SOLOMON H SNYDER VICE-CHAIRMAN 0.50 X X 0 0 0 MR STEVEN C MAYER TREASURER 2.00 X X 0 0 0 MRS WILLIAM MCCORMICK BLAIR JR SECRETARY 1.00 X X 0 0 0 DR MARIA C FREIRE UNTIL SEPT PRESIDENT & EXECUTIVE DIRECTOR 40.00 X X 458587 0 23200 DR KATHY BLOOMGARDEN BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR MARIJN DEKKERS BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MR JAMES H DONOVAN BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR PAUL L HERRLING BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR THOMAS R INSEL BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR JUDY LANSING KOVLER BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR RONALD L KRALL BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR FREDA LEWIS-HALL BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 JULIE BELL LINDSAY BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR EDISON T LIU BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MR JOEL S MARCUS BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DAME JILLIAN SACKLER BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MRS LILY SAFRA BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR CHARLES A SANDERS BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MR FRED SEIGEL BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR ELLEN V SIGAL BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MR RUSSELL W STEENBERG BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DR PAUL STOFFELS BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 ELIAS ZERHOUNI BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 GILBERT S OMENN BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 MRS WILLIAM M CAFRITZ UNTIL MAY BOARD OF DIRECTORS MEMBER 0.50 X 0 0 0 DAVID WHOLLEY FROM SEPT INTERIM PRES. & EXECUTIVE DIRECTOR 40.00 X 415304 0 38260 DONALD HILL CHIEF FINANCIAL OFFICER 40.00 X 264990 0 36642 KEVIN A KLOCK VP OF OPERATIONS & GENERAL COUNSEL 40.00 X 236844 0 34800 STEPHANIE JAMES SENIOR SCIENTIFIC ADVISOR 40.00 X 285699 0 22463 MICHAEL SANTOS VICE PRESIDENT OF SCIENCE 40.00 X 341916 0 30380 JULIE WOLF-RODDA SENIOR VP OF DEVELOPMENT 40.00 X 248167 0 34493 JOSEPH MENETSKI VP, RESEARCH PARTNERSHIPS 40.00 X 270098 0 34092 ROBERT BALTHASER VICE PRESIDENT OF ADVANCEMENT 40.00 X 171092 0 20719 STACEY ADAM ASSOCIATE VP, RESEARCH PARTNERSHIPS 40.00 X 235835 0 25932 DAVID O'BROCHTA SCIENTIFIC PROGRAM MANAGER 40.00 X 195268 0 31019 KAREN TOUNTAS SCIENTIFIC PROGRAM MANAGER 40.00 X 193750 0 22492 BRINDA DASS SCIENTIFIC PROGRAM MANAGER 40.00 X 188862 0 24049 STEVEN HOFFMANN ASSOCIATE VP, RESEARCH PARTNERSHIPS 40.00 X 187977 0 27608 3694389 0 406149 34 0 1 0 SWOG CTI 24 FRANK LLOYD WRIGHT DRIVE PO BOX ANN ARBOR MI 48105 CLINICAL TRIAL FOR LUNG MAP PROJECT 6280530 DANA-FARBER CANCER INSTITUTE 450 BROOKLINE AVENUE BOSTON MA 02215 THE PACT & CTDNA RESEARCH COLLABORATION 2521758 DELOITTE CONSULTING LLP 4022 SELLS DRIVE HERMITAGE TN 37076 COVID-19 PROJECT PROFESSIONAL SERVICES 2382326 THE UNIVERSITY OF TEXASMD ANDERSON PO BOX 4266 HOUSTON TX 77210 THE PACT PROJECT RESEARCH COLLABORATION 905317 THE BROAD INSTITUTE INC 415 MAIN STREET CAMBRIDGE MA 02142 THE CHIIME PROJECT RESEARCH COLLABORATIO 884421 32 60500 1250000 104683285 3684256 105993785 ADMINISTRATIVE REVENUE 900099 50000 50000 50000 1346882 1346882 11955373 11778361 177012 177012 177012 291800 60500 253788 38012 38012 107605691 50000 0 1561906 20124066 20124066 3500 3500 798005 798005 2967746 1436567 1482419 48760 5868953 3971368 1897585 514483 309430 195960 9093 1231077 781689 434363 15025 618512 317744 300768 190081 87892 102189 183504 183504 33712 27813 5899 10468 5871 4597 121563 44439 56938 20186 735559 179582 555977 140390 134401 5989 240478 240478 228032 135102 92930 PROGRAM CONTRACTS 19091057 19078577 12480 CONSULTANTS 4655198 4311705 326029 17464 RECRUITING 379759 30625 349134 HONORARIA 112000 112000 154493 65667 87084 1742 58402636 51956043 6334323 112270 66486739 47993053 41358911 67125693 235751 230354 2965720 1239951 1948833 1725769 59636280 101529635 2273227 3335255 171939741 221939759 7166950 8537356 1331478 338978 2237097 2114103 10735525 10990437 X 25368465 28544211 135835751 182405111 161204216 210949322 171939741 221939759 49203055 542051 0 X X 0 1 X 1 1 1 X 61322159 60444618 50623645 98343956 105993785 376728163 61322159 60444618 50623645 98343956 105993785 376728163 145478494 231249669 1066052 2057158 2818334 1722957 1346882 9011383 385739546 176383 0.59950 0.57280 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 1 0 0 0 0 1 0 0 0 0 PART II-B, LINE 1: FNIH CONSULTED ITS CONGRESSIONAL COMMITTEES OF JURISDICTION ON PUBLIC HEALTH LEGISLATION. 1 2700 14951 258599 1 1 0 0 20878035 3154350 544664 65915 24511134 14897505 5648998 419982 88450 20878035 12514811 1788682 705900 111888 14897505 11920726 1032217 -267231 103397 67504 12514811 9704030 1721204 552828 57336 11920726 0.76238 0.23762 0 0 1869159 460471 1408688 1096561 779480 317081 1725769 CHARITABLE GIFT ANNUITY 119864 DEFERRED LEASE INCENTIVE 1408688 DEFERRED RENT LIABILITY 585551 2114103 X 108512594 542051 294568 836619 107675975 183504 -253788 -70284 107605691 58767488 294568 253788 548356 58219132 183504 183504 58402636 PART V, LINE 4: THE FOUNDATION HAS ONE ENDOWMENT THAT IS FUNDED BY MULTIPLE DONORS TO SEED NEW DISCOVERIES AND/OR BE AVAILABLE TO RESPOND TO EPIDEMICS AND FOUNDATION'S UNANTICIPATED NEEDS. THE FOUNDATION'S OTHER ENDOWMENTS CONSIST OF INDIVIDUAL DONOR-RESTRICTED ENDOWMENT FUNDS ESTABLISHED FOR A VARIETY OF PURPOSE. (E.G. VARIETY OF RESEARCH AND EDUCATIONAL INITIATIVES AT THE FOUNDATION FOR THE NIH, INC). NET ASSETS ASSOCIATED WITH ENDOWMENT FUNDS ARE CLASSIFIED AND REPORTED BASED ON THE EXISTENCE OR ABSENCE OR DONOR-IMPOSED RESTRICTIONS. PART X, LINE 2: THE FOUNDATION IS EXEMPT FROM FEDERAL INCOME TAXES UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE; ACCORDINGLY, THE ACCOMPANYING FINANCIAL STATEMENTS DO NOT REFLECT A PROVISION OR LIABILITY FOR FEDERAL AND STATE INCOME TAXES. THE FOUNDATION HAS DETERMINED THAT IT DOES NOT HAVE ANY MATERIAL UNRECOGNIZED TAX BENEFITS OR OBLIGATIONS AS OF DECEMBER 31, 2021 AND 2020. PART XI, LINE 4B - OTHER ADJUSTMENTS: FUNDRAISING DIRECT EXPENSE -253,788. PART XII, LINE 2D - OTHER ADJUSTMENTS: FUNDRAISING DIRECT EXPENSE 253,788. 1 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM 0 0 GRANTMAKING 418164 EAST ASIA AND THE PACIFIC - AUSTRALIA, BRUNEI, BURMA, CAMBODIA, 0 0 GRANTMAKING 19892 SUB-SAHARAN AFRICA - ANGOLA, BENIN, BOTSWANA, BURKINA FASO, 0 0 GRANTMAKING 319949 NORTH AMERICA - CANADA 0 0 GRANTMAKING 40000 0 0 0 0 0 0 798005 0 798005 SUB-SAHARAN AFRICA - ANGOLA, BENIN, BOTSWANA, BURKINA FASO, RESEARCH 90523 WIRE TRANSFER 0 SUB-SAHARAN AFRICA - ANGOLA, BENIN, BOTSWANA, BURKINA FASO, RESEARCH 229426 WIRE TRANSFER 0 EAST ASIA AND THE PACIFIC - AUSTRALIA, BRUNEI, BURMA, CAMBODIA, RESEARCH 19892 WIRE TRANSFER 0 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM RESEARCH 418164 WIRE TRANSFER 0 NORTH AMERICA RESEARCH 40000 WIRE TRANSFER 0 1 4 0 0 0 0 0 0 PART I, LINE 2: PROGRAM AND GRANTS MANAGEMENT STAFF INVEST CONSIDERABLE EFFORT IN PROVIDING SCIENTIFIC, ADMINISTRATIVE, AND FISCAL OVERSIGHT FOR FNIH GRANTS. SCIENTIFIC AND TECHNICAL PROGRESS IS MONITORED THROUGH SEMI-ANNUAL AND ANNUAL REPORTS FROM THE GRANTEES AS WELL AS THROUGH DIRECT CONTACT WITH INVESTIGATORS BOTH BY TELECONFERENCE AND SITE VISITS, AND FOLLOW UP TO PROGRESS REPORTS AND SITE VISITS WHERE SCIENTIFIC QUESTIONS OR ADMINISTRATIVE ISSUES ARE IDENTIFIED. SCIENTIFIC REPORT SUBMISSIONS COVER A WIDE RANGE OF ITEMS INCLUDING INDIVIDUAL OBJECTIVES AND OVERALL PROGRESS REVIEW, MILESTONE ACHIEVEMENT, PROJECT PLAN UPDATE, AND ANY OTHER SIGNIFICANT CHANGES. FINANCIAL REPORTING IS REQUIRED ANNUALLY FOR ALL OF THE GRANTEES, AND SEMI-ANNUALLY FOR INSTITUTIONS THAT REQUIRE ADDITIONAL OVERSIGHT, SUCH AS SOME DEVELOPING COUNTRY INSTITUTIONS. DUE DILIGENCE PROCEDURES, SUCH AS FNIH COMPLIANCE WITH THE USA PATRIOT ACT AND IRS REQUIREMENTS ON EXPENDITURE RESPONSIBILITIES, HAVE BEEN INCORPORATED INTO THE REPORTING PROCESS TO ENSURE THAT THE GRANTEES ARE COMPLYING WITH GRANT, LEGAL, FINANCIAL, AND REGULATORY REQUIREMENTS. PART III ACCOUNTING METHOD: 2021 FNIH AWARD CEREMONY 352300 60500 291800 369 228081 2022 FNIH AWARD CEREMONY 25338 352300 60500 291800 369 253419 253788 38012 1 NIHCC - CLINICAL CENTER 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 346545 0 RESEARCH NIHNICCH 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 60000 0 RESEARCH NIHNCI 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 2139264 0 RESEARCH NIHNIAID 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 4937710 0 RESEARCH NIHNIAMS 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 2300000 0 RESEARCH NIHNINDS 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 751962 0 RESEARCH NIH NHLBI 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 69580 0 RESEARCH NIHOD 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 262000 0 RESEARCH NIH NIMH 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 4527895 0 RESEARCH NIHNIMHD 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 73330 0 RESEARCH NIHNIDA 9000 ROCKVILLE PIKE BETHESDA MD 20892 520858115 170(C)(1) GOVERNMENT 95000 0 RESEARCH REGENTS OF THE UOF CALIFORNIASAN FRANCISCO MISSION HALL 550 16TH STREET 2ND FLOOR SAN FRANCISCO CA 94143 946036493 501(C)(3) 17577 0 RESEARCH RESEARCH TRIANGLE INSTITUTE PO BOX 900002 RALEIGH NC 27675 560686338 501(C)(3) 345540 0 RESEARCH UNIVERSITY OF ALABAMA AT BIRMINGHAM DEPT OF PEDIATRIC ADMIN LOWDER BLDG 608 1600 7TH AVENUE SOUTH BIRMINGHAM AL 35233 636001138 501(C)(3) 71718 0 RESEARCH THOMAS JEFFERSON UNIVERSITY 125 SOUTH 9TH STREET 2ND FLOOR SHERIDAN BUILDING PHILADELPHIA PA 19107 231352651 501(C)(3) 186513 0 RESEARCH EMORY UNIVERSITY PO BOX 935084 ATLANTA GA 31193 580566256 501(C)(3) 357570 0 RESEARCH GEORGETOWN UNIVERSITY 37TH AND O STREETS NW BOX 571173 WASHINGTON DC 20057 530196603 501(C)(3) 15166 0 RESEARCH NORTH CAROLINA STATE UNIVERSITY - UNIVERSITY OF NORTH CAROLINA CHAPEL HILL 104 AIRPORT DRIVE SUITE 2200 CAMPUS BOX 1350 CHAPEL HILL NC 27599 800543561 501(C)(3) 147835 0 RESEARCH THE TRUSTEES OF COLUMBIA UNIVERSITY PO BOX 29789 GENERAL POST OFFICE NEW YORK NY 10087 135598093 501(C)(3) 401733 0 RESEARCH TRUSTEES OF INDIANA UNIVERSITY THE POPLARS BUILDING400 E SEVENTH ST BLOOMINGTON IN 47405 356001673 501(C)(3) 140303 0 RESEARCH UNIVERSITY OF VIRGINIA PO BOX 400195 CHARLOTTESVILLE VA 22904 546001796 501(C)(3) 118385 0 RESEARCH UNIVERSITY OF LOUISIANA AT LAFAYETTE 4401 W ADMIRAL DOYLE DRIVE NEW IBERIA LA 70560 726023836 501(C)(3) 436529 0 RESEARCH DUKE UNIVHUMAN VACCINE INSTITUTE 2200 WEST MAIN STREET SUITE 820 ERWIN SQUARE PLAZA DURHAM NC 27705 560532129 501(C)(3) 50641 0 RESEARCH FRED HUTCHINSON CANCER RESEARCH CTR 1100 FAIRVIEW AVE N SEATTLE WA 98109 237156071 501(C)(3) 149634 0 RESEARCH CATALYSIS FOUNDATION FOR HEALTH IN 1900 POWELL STREET SUITE 600 EMERYVILLE CA 94608 208602047 501(C)(3) 315621 0 RESEARCH UNIVERSITY OF PITTSBURGH 200 LOTHROP ST BIOMEDICAL SCIENCE TOWER W 950 PITTSBURGH PA 15213 250965591 501(C)(3) 905199 0 RESEARCH FRIENDS OF CANCER RESEARCH 1800 M STREET NW SUITE 1050 SOUTH WASHINGTON DC 20036 521983273 501(C)(3) 138296 0 RESEARCH TRANSLATIONAL GENOMICS RESEARCH INSTITUTE 446 N FIFTH STREET SUITE 600 PHOENIX AZ 85005 331092191 501(C)(3) 86764 0 RESEARCH LEIDOS BIOMEDICAL RESEARCH INC 1050 BOYLES STREET FREDERICK MD 21702 330653185 CORPORATE ENTITY NOT 675756 0 RESEARCH AND DEVELOPMENT 28 1 AWARDS 2 3500 FMV PART I, LINE 2: PROGRAM AND GRANTS MANAGEMENT STAFF INVEST CONSIDERABLE EFFORT IN PROVIDING SCIENTIFIC, ADMINISTRATIVE, AND FISCAL OVERSIGHT FOR FNIH GRANTS. SCIENTIFIC AND TECHNICAL PROGRESS IS MONITORED THROUGH SEMI-ANNUAL AND ANNUAL REPORTS FROM THE GRANTEES AS WELL AS THROUGH DIRECT CONTACT WITH INVESTIGATORS BOTH BY TELECONFERENCE AND SITE VISITS, AND FOLLOW UP TO PROGRESS REPORTS AND SITE VISITS WHERE SCIENTIFIC QUESTIONS OR ADMINISTRATIVE ISSUES ARE IDENTIFIED. SCIENTIFIC REPORT SUBMISSIONS COVER A WIDE RANGE OF ITEMS INCLUDING INDIVIDUAL OBJECTIVES AND OVERALL PROGRESS REVIEW, MILESTONE ACHIEVEMENT, PROJECT PLAN UPDATE, AND ANY OTHER SIGNIFICANT CHANGES. FINANCIAL REPORTING IS REQUIRED ANNUALLY FOR ALL OF THE GRANTEES, AND SEMI-ANNUALLY FOR INSTITUTIONS THAT REQUIRE ADDITIONAL OVERSIGHT, SUCH AS FOR-PROFIT INSTITUTIONS. DUE DILIGENCE PROCEDURES, SUCH AS FNIH COMPLIANCE WITH THE USA PATRIOT ACT AND IRS REQUIREMENTS ON EXPENDITURE RESPONSIBILITIES, HAVE BEEN INCORPORATED INTO THE REPORTING PROCESS TO ENSURE THAT THE GRANTEES ARE COMPLYING WITH GRANT, LEGAL, FINANCIAL, AND REGULATORY REQUIREMENTS. FELLOWS SELECTED FOR FOUNDATION FELLOWSHIPS ARE SELECTED THROUGH NATIONWIDE AND INTERNATIONAL COMPETITIONS. THE CLINICAL RESEARCH TRAINING PROGRAM (CRTP) IS OPEN TO ALL THIRD YEAR STUDENTS ENROLLED IN MEDICAL OR DENTAL SCHOOLS. THE WOMEN'S HEALTH FELLOWSHIP PROGRAMS ARE OPEN TO DOCTORAL-LEVEL CANDIDATES WITHIN FIVE YEARS OF RECEIPT OF THE DOCTORAL DEGREE. APPLICATIONS, CONTAINING TRANSCRIPTS AND ESSAYS ON THEIR RESEARCH GOALS ARE SUBMITTED AND REVIEWED BY PANELS OF NIH SCIENTISTS WHO MAKE RECOMMENDATIONS FOR SELECTION. POTENTIAL FELLOWS ARE OFTEN BROUGHT TO THE CAMPUS FOR INTERVIEWS AND FINAL SELECTION. THE FOUNDATION'S FELLOWSHIPS ARE OPEN TO PROFESSIONALS WORKING AT VARIOUS STAGES OF THEIR RESEARCH CAREERS. APPLICANTS TO THE NEUROSCIENCE FELLOWSHIP, FOR EXAMPLE, ARE YOUNG SCIENTISTS WHO WILL BENEFIT FROM EXPERIENCE OF CLINICAL AND BASIC SCIENCE RESEARCH. THE DIRECTOR'S FELLOWSHIP IN COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH SEEKS A MORE EXPERIENCED SCIENTIST WHO IS WELL-POSITIONED TO BECOME A LEADER IN THE FIELD OF COMPLEMENTARY ALTERNATIVE MEDICINE. X X X X X 0 0 0 0 0 0 0 0 0 DR MARIA C FREIRE UNTIL SEPT PRESIDENT & EXECUTIVE DIRECTOR 423587 0 35000 0 0 0 23200 0 0 0 481787 0 0 0 DAVID WHOLLEY FROM SEPT INTERIM PRES. & EXECUTIVE DIRECTOR 374004 0 35000 0 6300 0 23200 0 15060 0 453564 0 0 0 MICHAEL SANTOS VICE PRESIDENT OF SCIENCE 331916 0 10000 0 0 0 23200 0 7180 0 372296 0 0 0 STEPHANIE JAMES SENIOR SCIENTIFIC ADVISOR 285699 0 0 0 0 0 22463 0 0 0 308162 0 0 0 JOSEPH MENETSKI VP, RESEARCH PARTNERSHIPS 250098 0 20000 0 0 0 21732 0 12360 0 304190 0 0 0 DONALD HILL CHIEF FINANCIAL OFFICER 254990 0 10000 0 0 0 21532 0 15110 0 301632 0 0 0 JULIE WOLF-RODDA SENIOR VP OF DEVELOPMENT 240167 0 8000 0 0 0 20133 0 14360 0 282660 0 0 0 KEVIN A KLOCK VP OF OPERATIONS & GENERAL COUNSEL 226844 0 10000 0 0 0 19412 0 15388 0 271644 0 0 0 STACEY ADAM ASSOCIATE VP, RESEARCH PARTNERSHIPS 210835 0 25000 0 0 0 18852 0 7080 0 261767 0 0 0 DAVID O'BROCHTA SCIENTIFIC PROGRAM MANAGER 190268 0 5000 0 0 0 15909 0 15110 0 226287 0 0 0 KAREN TOUNTAS SCIENTIFIC PROGRAM MANAGER 191750 0 2000 0 0 0 15412 0 7080 0 216242 0 0 0 STEVEN HOFFMANN ASSOCIATE VP, RESEARCH PARTNERSHIPS 187977 0 0 0 0 0 15248 0 12360 0 215585 0 0 0 BRINDA DASS SCIENTIFIC PROGRAM MANAGER 185862 0 3000 0 0 0 15219 0 8830 0 212911 0 0 0 ROBERT BALTHASER VICE PRESIDENT OF ADVANCEMENT 171092 0 0 0 0 0 13639 0 7080 0 191811 0 0 0 X 2 25092 STOCK PRICE X 10 3659164 FMV 0 0 0 FORM 990, PART III, LINE 4A, PROGRAM SERVICE ACCOMPLISHMENTS CONTINUED: PARTNERSHIP FOR ACCELERATING CANCER THERAPIES (PACT) IMMUNOTHERAPIES TREATMENTS THAT STIMULATE THE BODY'S OWN IMMUNE SYSTEM TO FIGHT CANCER HAVE PROVEN TO BE AN EFFECTIVE AND PROMISING TREATMENT OPTION FOR CERTAIN CANCERS IN RECENT YEARS. YET THESE IMMUNOTHERAPY TREATMENTS DO NOT WORK FOR ALL PATIENTS, AND WE LACK A PRECISE UNDERSTANDING OF WHY. DEVELOPING STANDARDIZED BIOMARKER TESTS TO UNDERSTAND HOW IMMUNOTHERAPIES WORK IN SOME PATIENTS, AND THUS TO PREDICT PATIENT RESPONSES TO TREATMENT, IS URGENTLY NEEDED FOR THESE THERAPIES TO BENEFIT THE MAXIMUM NUMBER OF PEOPLE. PACT, A FIVE-YEAR PUBLIC-PRIVATE RESEARCH COLLABORATION LAUNCHED IN 2019 BY THE NIH, THE FNIH, THE FDA, AND 12 PHARMACEUTICAL COMPANIES AS PART OF THE CANCER MOONSHOT, INTEGRATES THE EXPERTISE OF RESEARCHERS AT FOUR TOP CANCER RESEARCH CENTERS DANA-FARBER CANCER INSTITUTE, STANFORD UNIVERSITY, MD ANDERSON CANCER CENTER, AND MOUNT SINAI MEDICAL CENTER TO DEVELOP THESE ASSAYS AND HARMONIZE THEM FOR USE ACROSS THE CANCER FIELD. TO DATE, PACT RESEARCHERS HAVE ANALYZED OVER 5,000 SAMPLES FROM 12 CLINICAL TRIALS IN DIFFERENT CANCERS AND USED THE RESULTING DATA TO VALIDATE EXISTING ASSAYS ACROSS ALL FOUR LABORATORIES. SIX EXISTING ASSAYS COMMONLY USED IN ASSESSING IMMUNOTHERAPIES AND COMBINATION THERAPIES ACROSS 15 DIFFERENT CANCERS HAVE BEEN HARMONIZED TO DATE. THE RESULTING STANDARDS HAVE BEEN PUBLISHED IN FOUR MAJOR JOURNAL ARTICLES TO MAKE SURE THESE TESTS CAN BE PERFORMED UNIFORMLY IN LABORATORIES ACROSS THE U.S. AS DATA ANTICIPATED FROM AN ADDITIONAL 35 TRIALS BECOMES AVAILABLE, PACT RESEARCHERS WILL BE ABLE TO USE IT TO HELP DEVELOP NEW BIOMARKERS TO HELP PHYSICIANS SELECT THE MOST OPTIMAL IMMUNOTHERAPY TREATMENTS FOR THEIR PATIENTS. MUCOSAL HEALING FOR ULCERATIVE COLITIS IN APRIL 2021, THE FNIH BIOMARKERS CONSORTIUM LAUNCHED ITS MUCOSAL HEALING IN ULCERATIVE COLITIS (UC) PROJECT TO IMPROVE DIAGNOSIS AND TREATMENT OF A DEBILITATING INFLAMMATORY BOWEL DISEASE THAT AFFECTS MORE THAN THREE MILLION PEOPLE WORLDWIDE. THIS THREE-YEAR INITIATIVE AIMS TO GENERATE BEST PRACTICES AND CONSENSUS STANDARDS FOR ASSESSING DISEASE ACTIVITY AT THE TISSUE-LEVEL IN UC CLINICAL TRIALS. THE PROGRAM ALSO HOPES TO DEVELOP CUTTING-EDGE METHODOLOGIES TO MEASURE MUCOSAL HEALING THE BODY'S ABILITY TO RESTORE INTESTINAL LINING DAMAGED BY UC, AND AN IMPORTANT OUTCOME IN CLINICAL TRIALS MORE ACCURATELY IN THE FUTURE. CREATING A MORE PRECISE MEASURE WITH WHICH TO JUDGE THE OUTCOME OF CLINICAL TRIALS PROMISES TO MEANINGFULLY ACCELERATE THE DEVELOPMENT OF NEW THERAPIES FOR PATIENTS WITH UC. THE ABILITY TO USE A COMMON PROTOCOL AND AUTOMATE THE EVALUATION OF MUCOSAL INFLAMMATION AND HEALING WILL ENABLE THESE MEASUREMENTS TO BE APPLIED MORE CONSISTENTLY, PRECISELY, AND RAPIDLY AND MAY REDUCE THE NUMBER OF BIOPSIES NEEDED. THE GOAL IS TO ADVANCE PHYSICIANS' ABILITY TO HELP GUIDE APPROPRIATE TREATMENT TO REDUCE OR EVEN PREVENT RELAPSES AND COMPLICATIONS, IMPROVING THE PATIENT EXPERIENCE. GENECONVENE IN THE MIDST OF AN ALREADY-STALLED GLOBAL STRUGGLE AGAINST MALARIA, COVID-19-RELATED DISRUPTIONS TO HEALTH CARE SYSTEMS PROMPTED A DANGEROUS RESURGENCE OF THIS DEADLY DISEASE IN 2020. RECOGNIZING THE URGENT NEED FOR NEW STRATEGIES, IN MAY 2021 THE WORLD HEALTH ORGANIZATION (WHO) WITH SUPPORT FROM FNIH'S GENECONVENE GLOBAL COLLABORATIVE PUBLISHED AN UPDATED GUIDANCE FRAMEWORK TO INFORM RESEARCH AND DEVELOPMENT OF GENETICALLY MODIFIED MOSQUITOES. MODIFYING THE GENES OF MALARIA-CARRYING MOSQUITOES CAN REDUCE THEIR ABILITY TO REPRODUCE, SO THAT THERE ARE FEWER TO SPREAD THE DISEASE, AND MAY DECREASE THE MOSQUITOES' ABILITY TO TRANSMIT THE MALARIA PARASITE. IF PROVEN SAFE, EFFECTIVE, AND AFFORDABLE, THESE TECHNOLOGIES COULD OFFER A GAME-CHANGING ADDITION TO THE EXISTING ARSENAL OF INTERVENTIONS AGAINST MALARIA. BUT THERE ARE MANY IMPORTANT QUESTIONS FOR DECISION MAKERS TO ADDRESS WHEN EVALUATING WHETHER AND HOW TO MOVE FORWARD WITH RESEARCH AND IMPLEMENTATION. THE FNIH-LED GENECONVENE INITIATIVE WORKS TO ENSURE THAT ALL STAKEHOLDERS INCLUDING RESEARCHERS, POLICYMAKERS, REGULATORS, AND COMMUNITIES AFFECTED BY MALARIA ARE EQUIPPED WITH THE RIGHT TOOLS TO MAKE INFORMED, RESPONSIBLE DECISIONS ABOUT THESE TECHNOLOGIES. THE NEW WHO GUIDANCE IS A SIGNIFICANT MILESTONE IN THIS EFFORT. IT PROVIDES ANSWERS TO SOME OF THE TOUGHEST QUESTIONS IN THE FIELD, INCLUDING: - HOW CAN THE POTENTIAL EFFECTIVENESS AND RISKS OF GENETICALLY MODIFIED MOSQUITOES ON REDUCING DISEASE BE EVALUATED? - WHAT ARE THE KEY ETHICAL CONSIDERATIONS? - WHICH REGULATORY FRAMEWORKS WILL OVERSEE DECISIONS ABOUT RESEARCH? LIKE MANY OTHER FNIH COLLABORATIONS, GENECONVENE CENTERS ON A CRITICAL INFLECTION POINT WHERE ADVANCES IN BIOMEDICAL RESEARCH DEPEND ON BRINGING DIVERSE GROUPS TOGETHER TO PURSUE A COMMON GOAL. WITH MALARIA CAUSING MORE THAN 600,000 DEATHS WORLDWIDE IN 2020 ALONE, THERE IS AN URGENT NEED TO EVALUATE THE PROMISE OF GENETICALLY MODIFIED MOSQUITOES BOTH QUICKLY AND RESPONSIBLY. GENECONVENE ALSO SERVES AS A GLOBAL HUB FOR RELEVANT, TIMELY AND ACCURATE KNOWLEDGE. A KEY RESOURCE FOR THIS WORK IS THE GENECONVENE VIRTUAL INSTITUTE, ALSO LAUNCHED IN 2020. THE VIRTUAL INSTITUTE IS AN ONLINE LIBRARY HOUSING SCHOLARLY LITERATURE, POLICY PAPERS, OPINION PIECES, EDUCATIONAL VIDEOS AND MEDIA COVERAGE. GENECONVENE ALSO HOSTS REGULAR WEBINARS THAT PROVIDE DIVERSE, MULTIDISCIPLINARY PERSPECTIVES ON THE SCIENTIFIC, SOCIAL AND ETHICAL DIMENSIONS OF GENETIC BIOCONTROL TECHNOLOGIES. REALIZING THE IMMENSE PROMISE OF GENETIC BIOCONTROL RESEARCH TO END MALARIA AND OTHER MOSQUITO-BORNE DISEASES OVER THE LONG TERM WILL REQUIRE A RIGOROUS EVALUATION OF THE RISKS AND BENEFITS OF EACH STEP ALONG THE WAY, FROM THE LABORATORY TO FIELD TESTING TO POTENTIAL IMPLEMENTATION. THROUGH THE GENECONVENE GLOBAL COLLABORATIVE, FNIH IS COMMITTED TO ENSURING THAT EVERYONE CHARGED WITH MAKING DECISIONS ABOUT GENETIC BIOCONTROLFROM SCIENTISTS TO POLICYMAKERS TO COMMUNITIESHAS THE KNOWLEDGE THEY NEED TO MOVE FORWARD SAFELY AND ETHICALLY. GENE DRIVE RESEARCH FORUM HUNDREDS OF PARTICIPANTS AROUND THE WORLD JOINED A 2021 SERIES OF VIRTUAL DISCUSSIONS COHOSTED BY GENECONVENE AND MCMASTER UNIVERSITY IN ONTARIO, CANADA, TO EXPLORE CRITICAL ETHICAL QUESTIONS RELATED TO GENE DRIVE. TOPICS INCLUDED THE ETHICAL PRINCIPLES THAT SHOULD GOVERN GENE DRIVE RESEARCH, AND JUSTICE AND EQUITY CONSIDERATIONS FOR APPLYING GENE DRIVE AT THE LOCAL COMMUNITY LEVEL. THE GENE DRIVE RESEARCH FORUM ORGANIZED BY GENECONVENE DEVELOPED THESE PANELS, AS WELL AS A COMPANION SERIES COHOSTED BY GENECONVENE AND THE GENETIC BIOCONTROL OF INVASIVE RODENTS (GBIRD) PARTNERSHIP THAT FOCUSED ON BEST PRACTICES FOR ENGAGING STAKEHOLDERS TO EXPLORE GENE DRIVE TECHNOLOGIES TOGETHER. COMPREHENSIVE CELLULAR VACCINE IMMUNE MONITORING CONSORTIUM (CCVIMC) IN JULY 2021, THE GATES FOUNDATION RENEWED FOR ANOTHER FIVE YEARS THE REMARKABLE WORK OF THE FNIH COMPREHENSIVE CELLULAR VACCINE IMMUNE MONITORING CONSORTIUM (CCVIMC). FOCUSED ON SUPPORTING THE DEVELOPMENT OF AN EFFECTIVE VACCINE FOR THE HIV VIRUS THAT CAUSES AIDS, THE CCVIMC CONVENES LEADING SCIENTISTS ACROSS THE GLOBE TO PROVIDE STANDARDIZED MEASUREMENTS FROM CLINICAL AND PRE-CLINICAL STUDIES OF THE DISEASE AND SHARE DATA TO OPTIMIZE VACCINE PLATFORMS BEING DEVELOPED THROUGH THE COLLABORATION FOR AIDS VACCINE DISCOVERY. GLOBALLY 1.5 MILLION PEOPLE ARE INFECTED WITH HIV ANNUALLY. OVER THE NEXT FIVE YEARS THE CCVIMC WILL CONTINUE TO BUILD ON RESEARCH ENABLING NEW APPROACHES TO HIV VACCINES TO BE STUDIED. THE END GOAL IS DEVELOPMENT OF A SAFE AND BROADLY EFFECTIVE VACCINE THAT WILL PREVENT HIV INFECTION. FORM 990, PART VI, SECTION A, LINE 1A THE BOARD HAS AN EXECUTIVE COMMITTEE, WHICH CAN MAKE DECISIONS ON BEHALF OF THE BOARD (WITH SOME EXCEPTIONS) IN BETWEEN BOARD MEETINGS. FORM 990, PART VI, SECTION A, LINE 2 MARIA FREIRE, THE FNIH PRESIDENT AND EXECUTIVE DIRECTOR UNTIL SEPTEMBER 2021, IS A NON-EXECUTIVE MEMBER OF THE BOARD OF DIRECTORS OF ALEXANDRIA REAL ESTATE. JOEL MARCUS IS THE CHAIRMAN AND CEO OF ALEXANDRIA REAL ESTATE AND A NON-EXECUTIVE MEMBER OF THE FNIH BOARD OF DIRECTORS. FORM 990, PART VI, SECTION A, LINE 4 THE FNIH BY-LAWS WERE AMENDED IN MAY 2021 TO MAKE CHANGES TO THE TERMS OF MEMBERS OF THE BOARD OF DIRECTORS. FORM 990, PART VI, SECTION B, LINE 11B PRIOR TO THE SUBMISSION OF THE FOUNDATION FOR NIH'S FORM 990 TO THE INTERNAL REVENUE SERVICE, EACH VOTING MEMBER OF THE BOARD OF DIRECTORS SHALL BE PROVIDED WITH A COPY OF THE DRAFT FORM 990 AS APPROVED BY THE CHIEF FINANCIAL OFFICER. FORM 990, PART VI, SECTION B, LINE 12C DIRECTORS, OFFICERS AND EMPLOYEES ARE REQUIRED TO ANNUALLY SIGN A STATEMENT WHICH AFFIRMS THAT THEY HAVE: O RECEIVED A COPY OF THE CONFLICT OF INTEREST POLICY O READ, UNDERSTOOD AND AGREED TO COMPLY WITH THE POLICY O RECEIVED AND REVIEWED A LISTING OF CORPORATE AND FOUNDATION DONORS, CONTRACTORS, VENDORS, GRANTEES, PRINCIPAL INVESTIGATORS AND FINANCIAL INSTITUTIONS WITH WHOM THE FNIH HAS A CURRENT RELATIONSHIP O NO ACTUAL OR APPARENT CONFLICTS OF INTEREST OTHER THAN THOSE DISCLOSED IN THE STATEMENT. THEY MUST ALSO MAKE CERTAIN NOTIFICATIONS IN PARTICULAR CIRCUMSTANCES. THE CONFLICT OF INTEREST POLICY ALSO HAS MECHANISMS FOR HANDLING SUCH CONFLICTS. FORM 990, PART VI, SECTION B, LINE 15 THE COMPENSATION COMMITTEE OF THE BOARD REVIEWED AND CONCURRED WITH THE PRESIDENT AND EXECUTIVE DIRECTOR'S DECISIONS ESTABLISHING AND ADJUSTING THE SENIOR EXECUTIVE TEAM'S ANNUAL SALARIES AND RELATED COMPENSATION DECISIONS. THE COMPENSATION COMMITTEE ALSO APPROVED THE COMPENSATION LEVEL OF THE PRESIDENT AND EXECUTIVE DIRECTOR AND RELATED COMPENSATION DECISIONS. FORM 990, PART VI, SECTION C, LINE 19 ALL SUCH DOCUMENTS ARE AVAILABLE UPON REQUEST. IN ADDITION, THE GOVERNING DOCUMENTS AND FINANCIAL STATEMENTS ARE AVAILABLE ON THE FNIH WEBSITE. FORM 990, PART XII, LINE 2C: PROCESS HAS NOT CHANGED FROM THE PRIOR YEAR.